Congenital Heart DiseaseOSCARNCT02710825
Osteopathy and Children With Congenital Heart Disease Surgery
A study testing Osteopathy and superficial palpatory agreement in people with Congenital Heart Disease, run by Hôpital Necker-Enfants Malades at 1 site in France.
Trial summary
Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by EVENDOL scale surgery on children with congenital heart disease Read more about this study
- Who is it for?
- Ages 5 days to 7 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Osteopathy and superficial palpatory agreement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to 23 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 days to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5 days to 7 years old
- Congenital heart sternotomy or thoracotomy operated
- Postoperative management at the Necker hospital in Paris, followed by Professor Damien Bonnet team
- Agreeing to participate of one of the holders of parental authority
- Oral Agreement child age
- Minimal knowledge of French language by parents
- Covered by the French social security system
Who cannot join
- Heart disease treated by interventional catheterization
- Postoperative complications requiring more than three weeks of intensive care
- Participation in an other biomedical research protocol
- Refusal or linguistic or mental disabilities or parents of the child
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in Children With Congenital Heart Disease Surgery
Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by EVENDOL scale surgery on children with congenital heart disease
Read the detailed description
The management of pain in children after cardiac surgery is the key to ensure a better comfort and fast home return.
Aside drugs and psychology or physical therapy, no other alternative is proposed in the medico-surgical unit of pediatric cardiology at the Necker hospital.
Following a feasibility study within the department, osteopathic care showed significant pain reduction in postoperative surgery assessed through the EVENDOL scale.
The goal was mainly to improve mobility restricted areas due to the operation, and so help to reduce post-operative pain.
Investigators propose to continue the assessment of the overall osteopathic taking care of the child after heart surgery while retaining EVENDOL scale as primary endpoint. Population will include children from the age of 5 days to less than 7 years old.
- Conditions
- Congenital Heart Disease
- Being tested
- Osteopathy, superficial palpatory agreement
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteopathyOther
The treatment begins, if possible, on the body part of the child whose osteopathic score is the highest , with the least elasticity and mobility. Then the other restricted joints will be treated. The set of techniques will be carried out after palpation and appropriate tensioning. The various actions will be carried out on the tissues and joints who have been particularly affected by the operation.
When a joint or tissue has a restricted mobility in a direction or a specific movement, it will require appropriate and gently manual correction, in order to reduce and improve its functionality.
superficial palpatory agreementOther
The simulated treatment also begins with the body part of the child whose osteopathic score is the highest. Then the other restricted joints will be treated. The set of techniques will be carried out with the same investments as the tests , with a superficial palpatory agreement and without tensioning so that the restricted articulation or tissue will not be corrected
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic treatment | Experimental | Not described Receives: Other: Osteopathy |
| Simulated osteopathic treatment | Placebo comparator | Not described Receives: Other: superficial palpatory agreement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of EVENDOL from day1 at day2
Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by doctor
Measured: day 2
Secondary outcomes (9)
Change of EVENDOL from day1 at day2
Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by children's parent (mother or father)
Measured: day 2
Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy
Osteopathic Scale assessing the mobility of each part of the body to give a final score OSCAR ranging from 0 to 45.
Measured: day 2
Change of Faces scale or Visual analog scale from day1 at day2
Pain Rating Scale and discomfort in children giving a score from 0 to 10 filled by child
Measured: day 2
Change of Arterial Pressure from day1 at day2
Measured: Day 2
Change of Oxygen saturation from day1 at day2
Measured: day2
Change of cardiac frequency from day1 at day2
Measured: day 2
Change of cardiac breathing frequency from day1 at day2
Measured: day2
Analgesic intake at day1
Doctor's drugs prescription
Measured: day1
Analgesic intake at day2
Doctor's drugs prescription
Measured: day2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Collaborators
- ARCFA : Association for research in cardiology foetal to adult
- Responsible party
- Principal investigator, Marion Hery, Hôpital Necker-Enfants Malades
- Investigators
- Fanny Bajolle, Ph, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710825
- Sponsor's protocol ID
- 2015-A01332-47
- Acronym
- OSCAR
- Status last verified
- Feb 2017
- First submitted
- 2 Mar 2016
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic manipulative treatment on pediatric patients with asthma: a randomized controlled trial. J Am Osteopath Assoc. 2005 Jan;105(1):7-12.
PubMed 15710659Degenhardt BF, Kuchera ML. Osteopathic evaluation and manipulative treatment in reducing the morbidity of otitis media: a pilot study. J Am Osteopath Assoc. 2006 Jun;106(6):327-34.
PubMed 16790538
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in Children With Congenital Heart Disease Surgery
- ClinicalTrials.gov ID
- NCT02710825
- Acronym / sponsor ID
- OSCAR / 2015-A01332-47
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Collaborators
- ARCFA : Association for research in cardiology foetal to adult
- Study start
- May 2016 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by EVENDOL scale surgery on children with congenital heart disease
Detailed description
The management of pain in children after cardiac surgery is the key to ensure a better comfort and fast home return.
Aside drugs and psychology or physical therapy, no other alternative is proposed in the medico-surgical unit of pediatric cardiology at the Necker hospital.
Following a feasibility study within the department, osteopathic care showed significant pain reduction in postoperative surgery assessed through the EVENDOL scale.
The goal was mainly to improve mobility restricted areas due to the operation, and so help to reduce post-operative pain.
Investigators propose to continue the assessment of the overall osteopathic taking care of the child after heart surgery while retaining EVENDOL scale as primary endpoint. Population will include children from the age of 5 days to less than 7 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic treatment | Experimental | Other: Osteopathy |
| Simulated osteopathic treatment | Placebo comparator | Other: superficial palpatory agreement |
Who may qualify
- Ages
- 5 days to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 5 days to 7 years old
- Congenital heart sternotomy or thoracotomy operated
- Postoperative management at the Necker hospital in Paris, followed by Professor Damien Bonnet team
- Agreeing to participate of one of the holders of parental authority
- Oral Agreement child age
Key exclusion criteria (4 listed)
- Heart disease treated by interventional catheterization
- Postoperative complications requiring more than three weeks of intensive care
- Participation in an other biomedical research protocol
- Refusal or linguistic or mental disabilities or parents of the child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsteopathyThe treatment begins, if possible, on the body part of the child whose osteopathic score is the highest , with the least elasticity and mobility. Then the other restricted joints will be treated. The set of techniques will be carried out after palpation and appropriate tensioning. The various actions will be carried out on the tissues and joints who have been particularly affected by the operation. When a joint or tissue has a restricted mobility in a direction or a specific movement, it will require appropriate and gently manual correction, in order to reduce and improve its functionality. | Other | Osteopathic treatment |
| superficial palpatory agreementThe simulated treatment also begins with the body part of the child whose osteopathic score is the highest. Then the other restricted joints will be treated. The set of techniques will be carried out with the same investments as the tests , with a superficial palpatory agreement and without tensioning so that the restricted articulation or tissue will not be corrected | Other | Simulated osteopathic treatment |
Primary outcome
Change of EVENDOL from day1 at day2
Time frame: day 2
Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by doctor
9 secondary outcomes
Change of EVENDOL from day1 at day2
Time frame: day 2
Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy
Time frame: day 2
Change of Faces scale or Visual analog scale from day1 at day2
Time frame: day 2
Change of Arterial Pressure from day1 at day2
Time frame: Day 2
Change of Oxygen saturation from day1 at day2
Time frame: day2
Change of cardiac frequency from day1 at day2
Time frame: day 2
Change of cardiac breathing frequency from day1 at day2
Time frame: day2
Analgesic intake at day1
Time frame: day1
Analgesic intake at day2
Time frame: day2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Background: PubMed 15710659Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic manipulative treatment on pediatric patients with asthma: a randomized controlled trial. J Am Osteopath Assoc. 2005 Jan;105(1):7-12.
- Background: PubMed 16790538Degenhardt BF, Kuchera ML. Osteopathic evaluation and manipulative treatment in reducing the morbidity of otitis media: a pilot study. J Am Osteopath Assoc. 2006 Jun;106(6):327-34.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny Bajolle, Ph study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathy and superficial palpatory agreement in people with Congenital Heart Disease, run by Hôpital Necker-Enfants Malades at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of EVENDOL from day1 at day2 (time frame: day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02710825, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.